Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Status:
Terminated
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
Summary
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent
than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind
trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these
studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up
to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials,
risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density
(BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more
potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to
bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer
patients has been well established; therefore, it is advantageous to assess the efficacy of
oral bisphosphonate therapy.
Phase:
Phase 3
Details
Lead Sponsor:
Christopher Sweeney, MBBS
Collaborators:
Hoosier Cancer Research Network Sanofi Walther Cancer Institute